Acute Myocardial InfarctionNCT04290949
Platelet Indices in Patients Undergoing Primary PCI and Its Prognostic Value
An observational study of Acute Myocardial Infarction, run by Assiut University.
Trial summary
To assess the platelet indices in patients undergoing primary percutaneous coronary intervention and its relation to the severity of coronary artery disease and short term clinical outcomes Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Myocardial Infarction
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2020to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 100 patients presented with acute myocardial infarction who undergoing primary percutaneous intervention
Who may be able to join
- Adult patients (age ≥ 18 years) that presented with acute ST elevation myocardial infarction
Who cannot join
- Cardiomyopathy,
- Previous revascularization procedure
- Any history of bleeding diathesis
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Platelet Indices in Patients Undergoing Primary Percutaneous Coronary Intervention :Its Relation to the Severity of Coronary Artery Disease and Its Prognostic Value
To assess the platelet indices in patients undergoing primary percutaneous coronary intervention and its relation to the severity of coronary artery disease and short term clinical outcomes
Read the detailed description
Acute coronary syndromes (ACS) is a type of acute coronary artery disease (CAD), It is a highly prevalent group of emergency diseases, associated with high morbidity and mortality (1)
ACS include ST- elevation Myocardial Infarction (STEMI), non ST-Elevation Myocardial Infarction (NSTEMI) and Unstable Angina (UA) (2).
ACS characterized by plaque rupture and acute thrombosis formation in the coronary arteries (3)
platelet morphology and function have vital roles in the pathogenesis of many diseases related to coagulation, thrombosis, inflammation, and endothelial dysfunction (4)
Platelets play a crucial role in thrombotic episodes, its activation is acritical factor in the creation and evolution of atherothrombosis. (5)
Not only platelets are essential for the thrombotic vascular occlusion at the ruptured atherosclerotic plaque but also they contribute to the obstruction and impairment of coronary micro circulation (6).
Risk stratification plays a crucial role in the management of patients with ACS (7).
Patients estimated to be at higher risk may be managed with earlier and more aggressive treatment, whereas those with lower risk may be managed with less intensive treatment (8).
Many biomarkers have been evaluated, and various scores have been created for risk stratification of ACS patients (9)
Mean platelet volume (MPV) has been proposed as a primary marker for platelet activation, as larger sized platelets have been associated with higher pro-thrombotic risk, and its measurement is easy and time effective (10-14)
- So It may elevate in patients with ACS and its role, It could be a useful bio marker of risk of stratification (15)
- Platelet Distribution Width (PDW) measured on admission is a cheap and generally available biomarker which allows for predicting the development of heart failure in patients with ACS after PCI (16) showed that an increased level of PDW was related to the severity of CAD in patients with ACS (17).
Numerous studies support the association of Mean platelet volume (MPV) with adverse cardiac outcomes as restenosis stent thrombosis in patients with ACS (19-24) al.2011
- Conditions
- Acute Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
the severity of coronary artery disease and short term clinical outcomes
Platelet indices as mean Platelet Volume (MPV)in femtoliter , platelet distribution width (PDW) (FL)% and (PCT)% May be larger and could be a risk of Stratification in patients undergoing primary percutaneous coronary intervention
Measured: follow up patients 6 monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start20 Feb 2020 (estimated)
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ishraq Hosny Abd El-Hameed Hassan, Assiut University
- Investigators
- Alaa El din Abd El Moniem, Professor, Study director, Critical Care Unit, Internal Medicine Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04290949
- Sponsor's protocol ID
- Platelet indices in acute MI
- Status last verified
- Feb 2020
- First submitted
- 30 Sep 2019
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Indices in Patients Undergoing Primary Percutaneous Coronary Intervention :Its Relation to the Severity of Coronary Artery Disease and Its Prognostic Value
- ClinicalTrials.gov ID
- NCT04290949
- Acronym / sponsor ID
- Platelet indices in acute MI
- Conditions
- Acute Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Feb 2020 (estimated)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 2 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the platelet indices in patients undergoing primary percutaneous coronary intervention and its relation to the severity of coronary artery disease and short term clinical outcomes
Detailed description
Acute coronary syndromes (ACS) is a type of acute coronary artery disease (CAD), It is a highly prevalent group of emergency diseases, associated with high morbidity and mortality (1)
ACS include ST- elevation Myocardial Infarction (STEMI), non ST-Elevation Myocardial Infarction (NSTEMI) and Unstable Angina (UA) (2).
ACS characterized by plaque rupture and acute thrombosis formation in the coronary arteries (3)
platelet morphology and function have vital roles in the pathogenesis of many diseases related to coagulation, thrombosis, inflammation, and endothelial dysfunction (4)
Platelets play a crucial role in thrombotic episodes, its activation is acritical factor in the creation and evolution of atherothrombosis. (5)
Not only platelets are essential for the thrombotic vascular occlusion at the ruptured atherosclerotic plaque but also they contribute to the obstruction and impairment of coronary micro circulation (6).
Risk stratification plays a crucial role in the management of patients with ACS (7).
Patients estimated to be at higher risk may be managed with earlier and more aggressive treatment, whereas those with lower risk may be managed with less intensive treatment (8).
Many biomarkers have been evaluated, and various scores have been created for risk stratification of ACS patients (9)
Mean platelet volume (MPV) has been proposed as a primary marker for platelet activation, as larger sized platelets have been associated with higher pro-thrombotic risk, and its measurement is easy and time effective (10-14)
- So It may elevate in patients with ACS and its role, It could be a useful bio marker of risk of stratification (15)
- Platelet Distribution Width (PDW) measured on admission is a cheap and generally available biomarker which allows for predicting the development of heart failure in patients with ACS after PCI (16) showed that an increased level of PDW was related to the severity of CAD in patients with ACS (17).
Numerous studies support the association of Mean platelet volume (MPV) with adverse cardiac outcomes as restenosis stent thrombosis in patients with ACS (19-24) al.2011
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 100 patients presented with acute myocardial infarction who undergoing primary percutaneous intervention
Key inclusion criteria (1 listed)
- Adult patients (age ≥ 18 years) that presented with acute ST elevation myocardial infarction
Key exclusion criteria (3 listed)
- Cardiomyopathy,
- Previous revascularization procedure
- Any history of bleeding diathesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the severity of coronary artery disease and short term clinical outcomes
Time frame: follow up patients 6 monthes
Platelet indices as mean Platelet Volume (MPV)in femtoliter , platelet distribution width (PDW) (FL)% and (PCT)% May be larger and could be a risk of Stratification in patients undergoing primary percutaneous coronary intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alaa El din Abd El Moniem, Professor study director
Critical Care Unit, Internal Medicine Department
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ishraq Hassan, Physician (+201065967424, Ishraqhosny@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the severity of coronary artery disease and short term clinical outcomes (time frame: follow up patients 6 monthes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2020.